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Test Code ADNA1 Double-Stranded DNA (dsDNA) Antibodies, IgG, Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.3 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Useful For

Evaluating patients with clinical features or at-risk for systemic lupus erythematosus (SLE)

 

Monitoring disease activity, as an adjunct test, in patients with SLE previously positive for double-stranded DNA IgG antibodies

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Reporting Name

dsDNA Ab, IgG, S

Specimen Type

Serum

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Reference Values

<100 IU/mL (negative)

≥100 IU/mL (positive)

Negative is considered normal.

Reference values apply to all ages.

Interpretation

A positive result for double-stranded DNA (dsDNA) IgG antibodies in the appropriate clinical context is suggestive of systemic lupus erythematosus (SLE). The performance characteristics of dsDNA IgG antibodies in SLE is dependent on the immunological method used for their detection, the patient's disease state including clinical manifestations, and demographics.

 

Weak-positive dsDNA IgG antibody results have a low-positive predictive value for SLE.

 

Negative results do not rule out a diagnosis of SLE.

Clinical Reference

1. Aringer M, Costenbader K, Daikh D, et al. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Arthritis Rheumatol. 2019;71(9):1400-1412. doi:10.1002/art.40930

2. Petri M, Orbai AM, Alarcon GS, et al. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012;64(8):2677-2686. doi:10.1002/art.34473

3. Infantino M, Manfredi M, Merone M, et al. Analytical variability in the determination of anti-double-stranded DNA antibodies: the strong need of a better definition of the old and new tests. Immunol Res. 2018;66(3):340-347. doi:10.1007/s12026-018-8992-9

4. Fox BJ, Hockley J, Rigsby P, Dolman C, Meroni PL, Ronnelid J, et al. A WHO Reference Reagent for lupus (anti-dsDNA) antibodies: international collaborative study to evaluate a candidate preparation. Ann Rheum Dis. 2019;78(12):1677-1680. doi:10.1136/annrheumdis-2019-21584

5. Ambrose N, Morgan TA, Galloway J, et al. Differences in disease phenotype and severity in SLE across age groups. Lupus. 2016;25(14):1542-1550. doi:10.1177/0961203316644333

6. Rekvig OP. Autoimmunity and SLE: Factual and semantic evidence-based critical analyses of definitions, etiology, and pathogenesis. Front Immunol. 2020;11:569234. doi:10.3389/fimmu.2020.569234

7. Bragazzi NL, Watad A, Damiani G, Adawi M, Amital H, Shoenfeld Y. Role of anti-DNA auto-antibodies as biomarkers of response to treatment in systemic lupus erythematosus patients: hypes and hopes. Insights and implications from a comprehensive review of the literature. Expert Rev Mol Diagn. 2019;19(11):969-978. doi:10.1080/14737159.2019.1665511

8. Damoiseaux J, Andrade LEC, Carballo OG, et al. Clinical relevance of HEp-2 indirect immunofluorescent patterns: the International Consensus on ANA patterns (ICAP) perspective. Ann Rheum Dis. 2019;78(7):879-889. doi:10.1136/annrheumdis-2018-214436

9. Choi MY, Clarke AE, St Pierre Y, et al. Antinuclear antibody-negative systemic lupus erythematosus in an international inception cohort. Arthritis Care Res (Hoboken). 2019;71(7):893-902. doi:10.1002/acr.23712

Day(s) Performed

Monday through Saturday

Report Available

2 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86225

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ADNA1 dsDNA Ab, IgG, S 33799-8

 

Result ID Test Result Name Result LOINC Value
ADNA1 dsDNA Ab, IgG, S 33799-8

Testing Algorithm

For more information see First-Line Screening for Autoimmune Liver Disease Algorithm.

Forms

If not ordering electronically, complete, print, and send a General Request (T239) with the specimen.